Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal

This study has been withdrawn prior to enrollment.
(Lack of interest in participation by patients locally and lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Mary E. Money, M.D., Money, Mary E., M.D.
ClinicalTrials.gov Identifier:
NCT01114113
First received: April 25, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance". Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.


Condition Intervention
Irritable Bowel Syndrome
Diarrhea
Drug: pancelipase/placebo
Device: SmartPill capsule

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea

Resource links provided by NLM:


Further study details as provided by Money, Mary E., M.D.:

Primary Outcome Measures:
  • Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo. [ Time Frame: 72 hour measurement per meal ] [ Designated as safety issue: No ]
    Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.


Enrollment: 0
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: non-trigger meal
Measurement of intestinal transport eating a "non-trigger meal".
Device: SmartPill capsule
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Active Comparator: "trigger meal baseline"
Measurement of intestinal transport after eating a "trigger meal".
Device: SmartPill capsule
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
Placebo Comparator: "trigger meal" with placebo
Measurement of intestinal transport with blinded placebo
Drug: pancelipase/placebo
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.
Device: SmartPill capsule
SmartPill capsule
Active Comparator: "trigger meal" with enzymes (blinded)
Measurement of intestinal transport with blinded active enzyme capsule
Drug: pancelipase/placebo
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.
Device: SmartPill capsule
SmartPill capsule

Detailed Description:

Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times. Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo. Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study. Willing participants will receive a small stipend each time they swallow the radio frequency capsule. This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
  2. The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
  3. In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
  4. The patient must be willing to comply with all of the study protocol.

Exclusion Criteria:

  1. The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
  2. The patient has nocturnal bowel movements.
  3. The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
  4. The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
  5. Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
  6. The patient reports daily use of laxatives or stool softeners; use of fiber supplementation is permitted.
  7. The patient is currently using pancrealipase. Previous use of pancrealipase in the past is allowed, but patients must be off either of the medication for at least 1 week or until the patient's symptoms of post prandial diarrhea returns before participating in the study.
  8. Use of implanted or ambulatory electromechanical medical devices such as pacemakers, insulin pumps, and infusion pumps.
  9. History of gastroparesis or chronic use of reglan.
  10. Dysphagia to solid food and pills.
  11. Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass or ulcer surgery.
  12. Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
  13. Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
  14. BMI > 35
  15. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114113

Sponsors and Collaborators
Money, Mary E., M.D.
Investigators
Principal Investigator: Mary E Money, M.D. Washington County Hospital
  More Information

Publications:
Responsible Party: Mary E. Money, M.D., Principal Investigator, Money, Mary E., M.D.
ClinicalTrials.gov Identifier: NCT01114113     History of Changes
Other Study ID Numbers: 2010IBS-G/D eval
Study First Received: April 25, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Money, Mary E., M.D.:
IBS-D
Post meal Diarrhea
Trigger meals

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014